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Model informed precision dosing for warfarin is to provide individualized dosing by integrating information related to patient characteristics, disease status and pharmacokinetics /pharmacodynamics of warfarin, through mathematical modeling and simulation techniques based on the quantitative pharmacology. Compared with empirical dosing, it can improve the safety, effectiveness, economy, and adherence of pharmacotherapy of warfarin. This consensus report describes the commonly used modeling and simulation techniques for warfarin, their application in developing and adjusting dosing regimens, medication adherence and economy. Moreover, this consensus also elaborates the detailed procedures for the implementation in the warfarin pharmacy service pathway to facilitate the development and application of model informed precision dosing for warfarin.
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OBJECTIVE:To provide the new idea for clinical pharmacists providing pharmaceutical care in oncology depart-ment. METHODS:Applying the principles and methods of clinical pathway,the pharmaceutical care of anti-tumor drugs could be divided into before medication,during medication,after medication and patient education,according to the sequence of taking med-icine. On the basis of evidence-based medicine,the care contents of each unit were established,and the pharmaceutical care path-way (PCP) was formed. During chemotherapy duration for a breast cancer metastasis patient with liver function injury,clinical pharmacists conducted pharmaceutical care for drug pretreatment,ADR monitoring and disposal,patient education,as well as put forward the proposal of drug treatment as supplementing calcium,adjusting the dose of epirubicin and paclitaxel targeting on PCP of zoledronic acid,epirubicin and paclitaxel. RESULTS:Physicians adopted the pharmacist’s recommendations. The patient suf-fered from joint and muscle pain during chemotherapy,and the symptom was relieved after symptomatic treatment by celecoxib;chest and back discomfort was relieved significantly after chemotherapy,and the disease condition kept stable. The patient was dis-charged from the hospital. CONCLUSIONS:PCP focus on the time,content and countermeasures of pharmaceutical care,the pro-gram and treatment results of pharmaceutical care,and promote standardization,formalization,simplification and procedure of pharmaceutical care. Clinical pharmacists conduct individualized pharmaceutical care rapidly targeting on PCP so as to deepen the communication of clinical pharmacists with physicians,nurses and patients,and promote the development of pharmaceutical care smoothly.
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OBJECTIVE:To provide reference for strengthening the management of drug off-label dosage in hospital. METH-ODS:PDCA cycle management was conducted to investigate the current situation of off-label dosage of Alprostadil injection (Li-po-PGE1)in endocrinology department of our hospital before Jul. 2012 in the Plan stage,identify problems,find reasons and devel-op intervention objectives and measures;after intervention in Do stage,medical advices were checked periodically in Check stage, and the data in the same stage of 2013 were spot-checked in Astage stage,intervention effect was analyzed and interventional pro-cess was standardized. RESULTS:Totally 943 medical advices,including 126 cases/times were analyzed before PDCA intervention and according to the data of cases,medical advices and drug usage amount,the incidences of off-label dosage were 39.68%, 31.50% and 47.90%,respectively;after a cycle of PDCA intervention,totally 414 medical advices,including 73 cases were ana-lyzed and the incidences of off-label dosage were 0. The prescribed daily dose(PDD)was decreased from 13.15 μg to the predeter-mined range(10.00 μg)with decrease rate of 23.95%;the drug use density(DUD)was decreased from 59.82 to 20.07 with de-crease rate of 66.45%. There were significant differences in among the incidence of off-label dosage,PDD and DUD of Lipo-PGE1 (P<0.05). It reached the expected targets. CONCLUSIONS:Because of its well-organized ideas on work and continuous improve-ment methods of circulation,PDCA cycle management provides a workable avenue to manage drug off-label dosage uses in hospital.
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Objective To explore the correlation of the TIAM2 functional gene mutations with the bleeding events in patients with coronary heart disease who undergone PCI and postoperative taken anti-platelet drug clopi-dogrel. Methods One hundred and twenty Chinese Han patients who had undergone PCI and postoperative taken anti-platelet drug clopidogrel were orderly enrolled from Guangdong General Hospital. Followed for 6 months after PCI, PCR sequencing was applied to test TIAM2 promoter region genotyping assay. Results After follow-up six months , 113 cases were remained lost of 7 cases , , including 19 cases with bleeding and 94 cases without bleed-ing; Bleeding risk in patients with diabetes mellitus (OR=3.115) or taking statins (OR=11.539), may be high, but there was no significant difference (P > 0.05); TIAM2 promoter region had three variants (c.3168+3116C>T, c.3168+3261A>G,c.3168+3596A>C), including wild-type, heterozygous, and homozygous. The probability of pa-tients with bleeding were 36.84%, 52.63%and 10.53%, and there is a certain chain of state , but the genotype was not significantly correlated with bleeding events of clopidogrel antiplatelet therapy (P>0.05). Conclusion Clopi-dogrel antiplatelet therapy bleeding events were not significantly correlated with TIAM2 functional gene mutation.
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OBJECTIVE:To probe into the tendency,characteristics and correlation factors of the allopurinol-induced adverse drug reactions(ADR). METHODS: The literature related to allopurinol-induced ADR retrieved from CNKI (between 1991 and 2008) as well as the allopurinol-induced clinical ADR cases collected in our hospital were summarized,analyzed and compared. RESULTS: A total of 77 ADR cases(reported in 76 papers) met the diagnostic criteria of ADR specified by Ministry of Public Health were collected,of which,10 cases(12.99%) died. A total of 67 clinical cases were collected from our hospital,of which,2 cases(2.99%) died,showing a high mortality rate. Mucocutaneous lesion was the chief ADR type,accounting for more than 90%,and the ADR chiefly appeared as drug rash and febrile and multiple organs or systems were often involved in the ADR. CONCLUSION: It is important to enhance ADR monitoring in clinical use of allopurinol.
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OBJECTIVE: To establish a method for endotoxin assay in aminoglycoside antibiotics for injection.METHODS: Kinetic turbidimetric limulus test was used for endotoxin assay in aminoglycoside antibiotics for injection.The recovery rate of bacterial endotoxin was determined though pre-interference experiments in which quantitative endotoxin was added to different concentrations of aminoglycosides with the concentration optimized,then an interference test on 4 different samples was conducted.RESULTS: At a concentration of 0.5 mg?mL-1,aminoglycosides didn't interfere with the limulus test if the amount of standard endotoxin was at 5.000,0.500,and 0.050 EU?mL-1,respectively.CONCLUSIONS: The kinetic turbidimetric limulus test could be used for endotoxin assay in aminoglycoside antibiotics for injection.
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Objective: The dynamic turbidimetry Limulus test was used to assay endotoxin content in Chuan Hu Ning injection. Methods: When the standardized endotoxin added in Chuan Hu Ning injection sample (Lot.No.000409) and in its 40-fold dilution, 80-fold dilution, 120-fold dilution and 200-fold dilution , the recovery was 0 %, 21.18 %, 76.69 %, 101.1 %and 117.8 %and as the standardized endotoxin added in the three batches of 200-fold dilution of Chuan Hu Ning injection (Lot.No.000408?000409?001023), the recovery was 110.5 %, 124.4 %and 87.98 %. Results: As standardized endotoxin concentration being 5.00, 0.500, 0.0500Eu/mL , the 200-fold dilution of Chuan Hu Ning injection is effective to eliminate the interference in the test. Conclusion: The dynamic turbidimetry Limulus test provides a new way for the determination of endotoxin in Chuan Hu Ning injection.
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Object To determine the bacterial endotoxin in BREVISCAPINI INJECTION (BI) by kinetic turbidimetric limulus test Methods By spiking the amount of standard endotoxin into BI sample, the interference test was fulfiled to detect the recovery in the range of 50% 200% Results A 12 fold dilution to BI sample is effective to eliminate the interference in limulus test Conclusion The kinetic turbidimetric limulus test provides an efficient way to detect the bacterial endotoxin in BI sample
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Objective: The kinetic turbidimetric limulus test was used in the endotoxin assay of Sodium Ferulate for injection. Methods: The preliminary validation test was fulfilled, when the standard endotoxin spiked in Sodium Ferulate for injection sample (Lot. No. 20000704) and its 10 fold dilution、 20 fold dilution、 40 fold dilution、 60 dilution、 80 fold dilution. The recoveries were 0.20%, 74.70%, 87.93%, 87.09%, 98.55%, 119.2% respectively. The optimum detection concentration found was 60 fold dilution. During the formal interference tests of 3 batches of Sodium Ferulate for injection (Lot. No. 20000308 20000704 20000315), the recoveries were 120.4%,98.55% and 85.40% respectively. Results: 5.00,0.500,0.0500 Eu/mL of standard endotoxin were used. The standard endotoxin was quantitatively added into the 60 fold dilution of Sodium Ferulate for injection. The recoveries were all 50%～200% and no interference action was found.Conclusion: The kinetict turbidimetric limulus test provided a new way to the detection of endotoxin in Sodium Ferulate for injection.
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AIM The kinetic turbidimetric Limulus test was used in the endotoxin assay of Ceftazidime injection. METHODS The validation test was fulfiled ,when the amount of endotoxin spiked in Ceftazidime injection sample(Lot.No.010202) in which concentration of its dilution solution were 10,5,2,1,0 5 g?L -1 . They were recovered in 60 08%, 82 90%, 85 22%, 94 00%, 92 67%; with the amount of endotoxin spiked in Ceftazidime sample (Lot.No. 010103, 010104, 010202),their 1 g?L -1 dilution were recovered in 109 9%, 101 7% and 86 56%. RESULTS With standard endotoxin working curve is 5 00, 0 500, 0 0500 ZU?L -1 . The 1 g?L -1 solution to Ceftazidime was effective to eliminate the interference in Limulus test. CONCLUSION The kinetic turbidimetric Limulus test provide a new way to the detection of endotoxin in Ceftazidime injection.